Rigid plastic protective case for a blister pack

ABSTRACT

A protective case for a blister pack containing medicines, includes a semi-rigid horizontal upper panel having cells delimiting housings open at the bottom and which are obturated by covers with each housing containing medicine. The case includes: perforated horizontal bottom upon which the lower face of the blister pack lays; and a perforated upper panel which covers the upper face of the blister pack; wherein the blister pack is trapped between the bottom and the upper panel each of which includes holes coinciding with the location of the cells, the case having elements for fixing the upper panel with respect to the bottom, and the bottom and the upper panel of the case are made of rigid plastic.

The invention relates to a protective case for a blister pack containingmedicines.

The invention relates more particularly to a protective case for ablister pack containing medicines intended for clinical trials, of thetype comprising a semi-rigid horizontal upper panel comprisingblister-shaped cells delimiting housings open at the bottom and whichare obturated by covers and each of which contains a medicine able to beexpelled by the flat lower face of the blister pack by tearing the coverof the blister.

The case is of the type comprising:

a perforated horizontal bottom upon which the lower face of the blisterpack lays; and

a perforated upper panel which covers the upper face of the blisterpack;

and of the type in which the blister pack is trapped between the bottomand the upper panel each of which comprise holes coinciding with thelocation of the cells, the case comprising means of fixing the upperpanel with respect to the bottom, the bottom and the upper panel of thecase being made of rigid plastic.

A medicine is subjected to clinical tests before being marketed. Forexample, the effectiveness of the medicine is tested by administeringthe active constituent to a first group of sick people and byadministering a placebo to a second control group of sick-people.

It is known to deliver the medicine sealed in a blister pack in a casein the form of a wallet with which is integrated an information noticerelating to the medicine that it contains. The blister pack is trappedin the case, or wallet, in such a way that the medicine is alwaysaccompanied by the corresponding notice.

In the context of clinical studies, referred to as double-blind, thecases must be indiscernible from each other whatever their contents maybe: placebo or active constituents.

According to a known example, the case consists of a folded sheet offlexible cardboard comprising a central panel flanked by two lateralflaps that can be folded down over the central panel.

The blister pack is trapped between the central panel and a firstlateral flap. The central panel and the first flap are each perforatedwith holes coinciding with the location of the cells. The perforatedflap is then folded down and then sealed on the central panel, forexample by pasting. The holes in the central panel allow the ejection ofthe medicine by pressure on the cell and tearing of the cover, themedicine then being retrieved under the lower face of the case.

The second lateral flap forms a protective lid for the cells of theblister pack. The information notice corresponding to the medicines islocated on one or both of the faces of the lid.

Such a case in particular makes it possible to use the contents of theblister pack without ever separating the notice. The switching ofmedicines or a placebo is thus prevented.

Furthermore, any attempt at tampering with the case generally results invisible damage.

However, such a case made of cardboard is flexible and deforms in use.Furthermore, the cardboard is more likely to become deformed if it isexposed to a damp atmosphere.

Furthermore, it can be envisaged that when a case is tampered with, thedamage may be camouflaged by pasting the perforated lateral flap backonto the central panel.

Finally, the packaging of the blister pack in such a case necessitates afirst operation of positioning of the blister pack in the pre-pastedcase and then an operation of pasting the perforated flap onto thecentral panel, which can take up to 7 seconds.

The document U.S. Pat. No. 3,587,517 describes a case which comprises arigid bottom upon which a rigid flap is mounted such that it rotatesabout a lateral hinge. A blister pack of medicine is intended to beinserted flat between the bottom and the flap. The bottom and the flapcomprise holes coinciding with the locations of the cells of the blisterpack. The case also comprises a rigid lid which is mounted such that itrotates with respect to the bottom between a position folded down overthe flap in such a way as to protect the cells from shocks and an openposition in which the cells are accessible.

However, this case is not suitable for use in the context of clinicaltrials. The case is in fact reusable, since the flap comprisesreversible means of closure with respect to the bottom. It is thereforepossible to substitute the original blister pack with a similar one butcontaining substances of different nature without the appearance of thecase revealing such a substitution. In order for the results of theclinical trials to be reliable, it is therefore essential that the caseshould be tamper-proof once the blister pack is trapped between thebottom and the flap.

In order to improve the packaging time and to solve the other problemsmentioned above, the invention proposes a case of the type describedpreviously, characterized in that the fixing means are elasticinterlocking means that cannot be dismantled.

According to other features of the invention:

the case comprises at least one pin forming a stop for the horizontalpositioning the blister pack with respect to the ejection holes in thebottom of the case;

the pin constitutes a male element of the elastic interlocking fixingmeans, the female element being carried by the upper panel;

the male element and the female element are formed in one piece with thebottom and with the top panel respectively;

the bottom comprises a rim that extends vertically upwards and whichsurrounds the upper panel;

the upper panel is a flap that is mounted such that it articulates abouta transverse axis by means of a first hinge on one side of the bottomwhich has no vertical rim;

the first hinge is formed by a plastic film which is formed in one piecewith the bottom and with the upper panel;

the first hinge forms a stop for positioning the blister pack withrespect to the holes in the bottom;

the case comprises an upper lid for protecting the cells which is madeof rigid plastic and which is mounted such that it pivots with respectto the bottom about a second hinge between a closed position in which itenvelopes the cells of the blister pack by cooperation of its shape withthat of the bottom, and an open position in which the cells areaccessible to a user;

the second hinge is a plastic film which is formed in one piece with thebottom and the lid;

the lid is held in the closed position by means working by cooperationof complementary shapes between the lid and the upper panel and/or thebottom;

the elastic interlocking is produced by elastic deformation of thefemale element.

Other features and advantages of the invention will appear on readingthe following detailed description given with reference to the appendeddrawings among which:

FIG. 1 is an exploded perspective view of a case produced according tothe invention, the case being open and unfolded, ready to receive ablister pack of medicines;

FIG. 2 shows the case of FIG. 1 with its lid in the open position whichshows the blister pack of medicines trapped in the case;

FIG. 3 is a plan view which shows the bottom of the case upon which theblister pack of medicine is positioned;

FIG. 4 is a perspective view in partial cross-section through thecross-sectional plane 4-4 of FIG. 2 showing in detail the elasticinterlocking fixing means of the intermediate flap on the bottom of thecase before the interlocking has taken place;

FIG. 5 is a view showing the fixing means of FIG. 4 after theinterlocking has taken place;

FIG. 6 shows the case of FIG. 1 with its lid in the closed position andwhich comprises an information notice;

FIG. 7 is a large scale view in longitudinal cross-section through thecross-sectional plane 7-7 of FIG. 6.

In the rest of the description, and in a non-restrictive way, alongitudinal, vertical and transverse orientation will be used asindicated by the coordinate system L, V, T shown in FIG. 1.

FIG. 1 shows a case 10 for protecting a blister pack 12 of medicines.The case 10 is empty in this case and it is in an original unfoldedstate in which it is ready to receive the blister pack of medicines 12.

In a known way, the blister pack 12 comprises a semi-rigid horizontalupper panel 14 which comprises blister-shaped cells 16 delimitinghousings open in the downward direction which are obturated by covers 17as shown in FIG. 7. Each of the housings can house a medicine 19 thatcan be expelled through the flat lower face 18 of the blister pack 12 bydeformation of the cell 16 and by tearing of the cover 17 as illustratedby the central cell 16 in FIG. 7. The medicines 19 are for example inthe form of tablets, capsules or suppositories suitable for protectionby a blister pack.

The case 10 comprises in particular a central bottom 20 which isprincipally formed by a horizontal panel of overall rectangular shapewhose short front 22 and rear 24 sides are oriented in the transversedirection and whose long sides 26 and 28 are oriented in thelongitudinal direction according to FIG. 1.

The bottom 20 is in particular intended to support the flat lower face18 of the blister pack 12 which is placed in position in the directionof the arrow F shown in FIG. 1.

The bottom panel 20 comprises a lateral rim 30 which extends verticallyupwards from the two long sides 26 and 28 and from the short rear edge24.

A flat rectangular flap 32, whose dimensions are substantiallycomplementary to those of the bottom 20, is mounted such that itarticulates about a front transverse hinge 34, on the short front side22 of the bottom 20, between an unfolded position and a folded downposition.

In the unfolded position, as shown in FIG. 1, the flap 32 totallyuncovers the bottom 20 of the case 10.

In the folded down position, as shown in FIGS. 2 and 7, the flap 32totally covers the bottom 20 in such a way as to trap the blister pack12 between the lower face 36 of the flap 32 and the upper face 38 of thebottom 20. The flap 32 is then surrounded by the rim 30 of the bottom20.

The flap 32 and the bottom 20 comprise holes 40 and 42 respectivelywhich are formed such that they coincide with the locations of the cells16 of the blister pack 12 when the flap 32 is in the folded downposition. The cells 16 and the holes 40 and 42 are in this case producedin the form of four longitudinal rows of nine units.

As shown in FIG. 2, the holes 40 of the flap 32 provide the user withaccess to the cells 16 such that the user can thus select a medicine 19and eject it by pressing vertically on the chosen cell 16, the medicine19 then being ejected through the cover 17 and through the correspondinghole 42 in the bottom 20 as illustrated by the arrow F′ shown in FIG. 7.

The case 10 comprises non-detachable or tamper-proof means of fixing theflap 32 in the position in which it is folded down on the bottom 20. Theflap 32 is more precisely fixed by the vertical elastic interlocking ofa series of pairs of elements each comprising a male element 44 and afemale element 46. The fixing means are shown in greater detail in FIGS.4 and 5.

The male element 44 consists of a pin 48 that extends vertically upwardsfrom the upper face 38 of the bottom 20. The free end of the pin 48comprises a hemispherical head 50 whose horizontal flat faces downwards.

The pin 48 is intended to cooperate with the corresponding femaleelement 46 which is carried by the flap 32. According to thisembodiment, the female element 46 is a pit 54 with a pierced bottomwhich extends vertically from the upper surface 56 of the flap 32. Thepit 54 comprises a lower opening 52 intended to receive thehemispherical head 50 of the pin 48.

The pit 54 also comprises vertical slits which divide the pit 54 intotwo symmetrical halves in order to facilitate its elastic deformationand consequently the interlocking with the male element 44.

Thus, when the pin 48 is interlocked in the female element 46, as shownin FIG. 5, the upper end of the pit 54 is butted against thedownward-facing flat of the pin 48 in order to prevent any verticalmovement of the flap 32 with respect to the bottom 20. The flap 32 isthus firmly attached to the bottom 20 and the blister pack 12 is trappedin the case 10.

Furthermore, the pit 54 has the shape of a truncated cone whose lowerend is located in the opening 52 and which is intended to increase theresistance to unlocking by pinching effect.

As can be seen in FIG. 1, the interlock orifices 52 of the flap 32 areencircled by a skirt 58 for protecting the pairs on fixing elements 44,46 and which extends vertically from the upper surface 56 of the flap 32and which prevents any attempt at dismantling by separating the twohalves of each pit 54.

As seen in FIG. 3, the pairs of elastic interlocking fixing elements 44,46 are six in number in this case. The pins 48 carried by the bottom 20are distributed around the periphery of the bottom 20 at the rate of twolateral pins 48L on each of the long sides 26 and 28 of the bottom 20and two frontal pins 48F on the rear short side 24. The pins 48determine precisely the horizontal position of the blister pack 12 withrespect to the ejection holes 42 when the latter is placed in the bottom20 and before folding down the flap 32. The short front side 22 of theblister pack 12 is adjacent to the front hinge 34.

The pins 48 and the front hinge 34 thus advantageously form positioningstops for the blister pack 12 with respect to the bottom 20.

The case 10 also comprises a lid 60 which is particularly visible inFIGS. 2 and 6. The lid 60 is a panel whose overall dimensions aresimilar to those of the bottom 20. The lid 60 is mounted such that itarticulates on the upper edge of the rim 30 of the short rear side 24,about a transverse rear hinge 62, between an open position and a closedposition.

In the open position, as shown in FIG. 2, the lid 60 uncovers the upperpart of the blister pack 12 in such a way as to provide the user withaccess to the medicines 19. The lid can be opened through 180° providingtotally free access to the blister pack.

In the closed position, as shown in FIG. 6, the lid 60 is globallyhorizontal and its lower reverse side 64 is pressed against the upperedge of the rim 30 of the bottom 20. The lid 60 comprises at its freeend, that is to say the side opposite to that of the rear hinge 62, aflange 66 which extends perpendicularly from its reverse side 64 in sucha way as to close the short front side 22 of the case 10 which does nothave a vertical rim 30.

The lid 60 therefore encloses and protects the upper face 14 of theblister pack 12 and, in particular, the cells 16. In the closedposition, only the obverse side 68 of the lid 60 is visible.

The obverse side 68 of the lid 60 can in particular serve as a supportfor a notice 70 giving information on the medicines 19 contained in thecase 10. The notice 70 is for example pasted on the obverse side 68 oron the reverse side 64. The notice can also be printed or inscribed onthe lid in sunken or in raised form.

The flap 32 comprises two tabs 72 which make it protrude beyond thefront hinge 34. In the folded down position of the flap 32, these twotabs 72 extend horizontally from the short front side 22 of the case 10.

The tabs 72 are designed to hook the lid 60 in the closed position byelastic interlocking with grooves (not shown) formed in the flange 66 ofthe lid 60.

In the centre of the flange 66 of the lid 60 there is a protrusion 74forming a grip to allow the user to disengage the lid 60 from theengagement of the tabs 72 in order to open the case 10 by raising it.

The case 10 is in this case made entirely of rigid plastic. The case 10is thus resistant to shocks and its mechanical properties are not harmedby exposure to a damp atmosphere.

According to this embodiment, the case 10 is made in one piece bymolding. The front 34 and rear 62 hinges are therefore each formed by aplastic film which is continuous with the bottom 20. The case 10 isadvantageously made from a material of the polypropylene type such thatrepeated openings and closings of the lid 60 do not cause any fracturingby fatigue of the rear hinge 62 during the use of the case 10.

The pins 48 are also made in one piece with the bottom 20 and the femaleelements are made in one piece with the flap 32. The manufacture of thiscase 10 does not therefore necessitate any assembly operation since itconsists of a single part.

During the operation of packaging the blister pack 12 in the case 10, anoperator places the blister pack 12, with the cells 16 uppermost, on thebottom 20 between the pins 48 as illustrated by the arrow F in FIG. 1,the case 10 being unfolded, with its three sections 20, 32 and 60horizontal such as they are on removal from the mould.

Then, the flap 32 is folded down on top of the blister pack 12 againstthe bottom 20. The blister pack 12 is therefore automatically positionedsince the folding formed at the level of the front hinge 34 by the flap32 and the bottom 20 pushes the blister pack 12 which is guidedlaterally into position by the lateral pins 48L and is stopped whenbutted against the frontal pins 48F.

The pits 54 of the flap 32 are then brought vertically into contact withthe pins 48 which penetrate through the lower openings 52. The convexhead 50 of the pin 48 elastically separates the two halves of the pit54. The pit 54 then returns elastically to its original shape againstthe pin 48, under the head 50. The pairs of fixing elements 44 and 46are then in an interlocked position and the flap 32 thus traps theblister pack 12 against the bottom 20 in such a way that it cannot bedismantled.

Because of this case 10, it is not necessary to position the blisterpack 12 exactly in the case 10 since the exact positioning is obtainedwhen the flap 32 is folded down and then fixed. This method of fixing isadvantageously fast and does not call upon any external means.

During the use of the case 10, the user grasps the closed case 10 bysupporting the lower face of the bottom 20 in the palm of his hand andby squeezing the two long lateral sides 26 and 28 between his fingers.Then he uses his other hand to open the lid 60 of the case 10 by raisingthe protrusion 74. Finally, with a finger, he presses the cell 16containing the desired medicine 19 in order to eject it through the hole42 in the bottom 20, into the palm of his hand which is supporting thecase 10.

Such a case 10 makes any attempt at tampering with it in order to removethe blister pack 12 difficult.

In fact, as the flap 32 is surrounded very closely by the rim 30 of thebottom 20, it is difficult to obtain purchase for inserting a lever intothe interstice between the flap 32 and the bottom 20 for the purpose ofraising the flap 32.

It is also difficult to attempt to separate the blades 54 which edge theinterlock orifice 52 of the flap 32 in order to release the head 50 ofthe corresponding pin 48 since the periphery of the orifice 52 isprotected by the skirt 58. Furthermore, it would be necessary to carryout this operation simultaneously on the six fixing means because of therigidity of the flap 32.

Therefore, the only method of reaching the blister pack 12 is to cut offthe heads 50 of each pin 48, which leaves traces that cannot beeradicated. That is to say that, in the case of tampering, the case 10bears traces that are impossible to camouflage.

In a variant of the invention, which is not shown, the flap 32 and thebottom 20 are two separate parts.

1. A protective case (10) for a blister pack (12) containing medicines(19) intended for clinical trials, of the type comprising a semi-rigidhorizontal upper panel (14) comprising blister-shaped cells (16)delimiting housings open at the bottom and which are obturated by covers(17) and each of which contains a medicine (19) able to be expelled bythe flat lower face (18) of the blister pack (12) by tearing the cover(17) of the blister (12), and of the type wherein the case (10)comprises: a perforated horizontal bottom (20) upon which the lower face(18) of the blister pack (12) lays; and a perforated upper panel (32)which covers the upper face (14) of the blister pack (12); and of thetype in which the blister pack (12) is trapped between the bottom (20)and the upper panel (32) each of which comprise holes (40, 42)coinciding with the location of the cells (16), the case comprisingmeans (44, 46) of fixing the upper panel (32) with respect to the bottom(20), the bottom (20) and the upper panel (32) of the case (10) beingmade of rigid plastic, characterized in that the fixing means (44, 46)are elastic interlocking means that cannot be dismantled.
 2. The case(10) as claimed in claim 1, characterized in that it comprises at leastone pin (48) forming a stop for the horizontal positioning of theblister pack (12) with respect to the ejection holes (42) in the bottom(20) of the case (10).
 3. The case (10) as claimed in claim 2,characterized in that the pin (48) constitutes a male element (44) ofthe elastic interlocking fixing means, the associated female element(46) being carried by the upper panel (32).
 4. The case (10) as claimedin claim 1, characterized in that the male element (44) and the femaleelement (46) are formed in one piece with the bottom (20) and with thetop panel (32) respectively.
 5. The case (10) as claimed in claim 1,characterized in that the bottom (20) comprises a rim (30) that extendsvertically upwards and which surrounds the upper panel (32).
 6. The case(10) as claimed in claim 1, characterized in that the upper panel is aflap (32) that is mounted such that it articulates about a transverseaxis by means of a first hinge (34) on one side (22) of the bottom (20)which has no vertical rim (30).
 7. The case (10) as claimed in claim 6,characterized in that the first hinge (34) is formed by a plastic filmwhich is formed in one piece with the bottom (20) and with the upperpanel (32).
 8. The case (10) as claimed in claim 6, characterized inthat the first hinge (34) forms a stop for positioning the blister pack(12) with respect to the holes (42) in the bottom (20).
 9. The case (10)as claimed in claim 5, characterized in that it comprises an upper lid(60) for protecting the cells (16) which is made of rigid plastic andwhich is mounted such that it pivots with respect to the bottom about asecond hinge (62) between a closed position in which it envelopes thecells (16) of the blister pack (12) by cooperation of its shape withthat of the bottom (20), and an open position in which the cells (16)are accessible to a user.
 10. The case (10) as claimed in claim 9,characterized in that the second hinge (62) is a plastic film which isformed in one piece with the bottom (20) and the lid (60).
 11. The case(10) as claimed in claim 9, characterized in that the lid (60) is heldin the closed position by means working by cooperation of complementaryshapes (72) between the lid (60) and the upper panel (32) and/or thebottom (20).
 12. The case (10) as claimed in claim 1, characterized inthat the elastic interlocking is produced by elastic deformation of thefemale element (46).
 13. The case (10) as claimed in claim 7,characterized in that the first hinge (34) forms a stop for positioningthe blister pack (12) with respect to the holes (42) in the bottom (20).14. The case (10) as claimed in claim 6, characterized in that itcomprises an upper lid (60) for protecting the cells (16) which is madeof rigid plastic and which is mounted such that it pivots with respectto the bottom about a second hinge (62) between a closed position inwhich it envelopes the cells (16) of the blister pack (12) bycooperation of its shape with that of the bottom (20), and an openposition in which the cells (16) are accessible to a user.
 15. The case(10) as claimed in claim 7, characterized in that it comprises an upperlid (60) for protecting the cells (16) which is made of rigid plasticand which is mounted such that it pivots with respect to the bottomabout a second hinge (62) between a closed position in which itenvelopes the cells (16) of the blister pack (12) by cooperation of itsshape with that of the bottom (20), and an open position in which thecells (16) are accessible to a user.
 16. The case (10) as claimed inclaim 8, characterized in that it comprises an upper lid (60) forprotecting the cells (16) which is made of rigid plastic and which ismounted such that it pivots with respect to the bottom about a secondhinge (62) between a closed position in which it envelopes the cells(16) of the blister pack (12) by cooperation of its shape with that ofthe bottom (20), and an open position in which the cells (16) areaccessible to a user.
 17. The case (10) as claimed in claim 10,characterized in that the lid (60) is held in the closed position bymeans working by cooperation of complementary shapes (72) between thelid (60) and the upper panel (32) and/or the bottom (20).